research study to compare a new medicine "fast-acting insulin aspart" to another medicine "insulin aspart" in chinese people with diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. the study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). participants will either get faster aspart or insulin aspart (novorapid®) - which treatment is decided by chance. both medicines will be taken together with insulin degludec. participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. all study medicines are provided in pens. a pen is a tool to inject insulin under the skin.the study will last for about 7 months (30 weeks). participants will have 11 clinic visits and 17 phone contacts with the study doctor. at 8 clinic visits participants will have blood samples taken. at 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. participants will fill in a diary the last 3 days before the visits/phone contacts. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent * diagnosed with diabetes mellitus, type 1 (t1dm) at least or equal to 1 year prior to screening or diagnosed with diabetes mellitus, type 2 (t2dm) at least or equal to 5 years prior to screening * treated with a basal-bolus insulin regimen or a premix insulin regimen at least or equal to 1 year prior to screening. insulin regimen must be unchanged within 60 days prior to screening. a basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin taken with meals at least thrice daily. a premix insulin regimen is defined as premix insulin twice or thrice daily * for subjects with t1dm: not treated with any oral anti-diabetes drugs (oads) for at least 90 days prior to screening. for subjects with t2dm: not treated with any oads or treated with 1-2 oads within 90 days prior to screening. allowed oads are metformin, alpha-glucosidase inhibitor, sodium-glucose co-transporter-2 inhibitors (sglt2i) and dipeptidyl peptidase-4 inhibitors (dpp4i). change in oad and dose prior to screening is allowed. * hba1c 7.5-9.5% (both inclusive) as assessed by central laboratory at screening exclusion criteria: * any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening * subjects presently classified as being in new york heart association (nyha) class iv * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening * anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)